Lamotrigine Orally Disintegrating Tablet (ODT)

Lamotrigine Orally Disintegrating Tablet (ODT) is an anti-epileptic medication used to help control certain kinds of seizures or to treat bipolar disorder. There are several immediate release formulations of this medication that can be used such as immediate-release tablets, chewable tablets, and orally disintegrating tablets. For members who cannot swallow a pill, lamotrigine chewable tablet is a viable alternative option to Lamotrigine ODT.

Definitions

"Anti-epileptics" refers to medications used to treat seizures. "Epilepsy" is a chronic neurological disorder characterized by the tendency to have recurrent unprovoked seizures. Two or more of these seizures occurring more than 24 hours apart can be indicative of this syndrome.

"Bipolar Disorder" is a mental health condition marked by extreme mood swings that include episodes of depression (lows) and mania (highs). It is a long-term, or chronic, condition that requires ongoing management.

Medical Necessity Criteria for Initial Authorization

The Plan considers Lamotrigine ODT medically necessary when ALL the following criteria are met for the applicable indication listed below:

For the treatment of Seizure Disorders:

1. The member is 2 years of age or older; AND
2. The member has ONE (1) of the following diagnoses:
   • partial-onset seizures; or
   • primary generalized tonic-clonic (PGTC) seizures; or
   • generalized seizures of Lennox-Gastaut syndrome; or
   • absence seizures; AND
3. The member is unable to use or has tried and failed BOTH of the following:
   • Lamotrigine immediate-release; and
   • Lamotrigine chewable tablet; AND
4. Lamotrigine ODT is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND
5. Clinical chart documentation is provided for review to substantiate the above listed requirements.

For the treatment of Bipolar Disorder:

1. The member is 18 years of age or older; AND
2. The member has a diagnosis of bipolar disorder; AND
3. The member is unable to use or has tried and failed BOTH of the following:
   • Lamotrigine immediate-release; and
   • Lamotrigine chewable tablet; AND
4. Lamotrigine ODT is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND
5. Clinical chart documentation is provided for review to substantiate the above listed requirements.

For other off-label uses:

1. The member is 18 years of age or older; AND
2. The medication is being requested for ONE of the following:
   • acute treatment of bipolar major depression; or
   • prophylactic therapy to decrease severity and frequency of short-lasting unilateral neuralgiform headache attacks; or
   • management of symptoms associated with trigeminal neuralgia; AND
3. The member is unable to use or has tried and failed BOTH of the following:
   • Lamotrigine immediate-release; and
   • Lamotrigine chewable tablet; AND
4. Lamotrigine ODT is being prescribed within the manufacturer’s published dosing guidelines or falls within dosing guidelines found in a compendia of current literature; AND
5. Clinical chart documentation is provided for review to substantiate the above listed requirements.

If the above prior authorization criteria is met, lamotrigine ODT will be approved for up to 12 months.

Medical Necessity Criteria for Reauthorization

Reauthorization for 12 months will be granted if the member has chart documentation demonstrating a clinical improvement in symptoms since starting the requested medication:

For the treatment of epilepsy:

• The member has demonstrated a reduction in severity and/or frequency of seizures.

For the treatment of bipolar disorder:

• The member's condition has improved or stabilized based upon the prescriber's assessment.

For other off-label uses:

• The member’s condition has demonstrated improvement, as validated by clinical assessment.

Experimental or Investigational / Not Medically Necessary

Lamotrigine ODT for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Bendtsen L, Zakrzewska JM, Abbott J, et al. European Academy of Neurology guideline on trigeminal neuralgia. Eur J Neurol. 2019;26(6):831-849. doi:10.1111/ene.13950
2. Bobo WV, Shelton RC. Bipolar major depression in adults: Efficacy and adverse effects of antidepressants. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 21, 2022.
3. Cohen AS. Short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing. Cephalalgia. 2007;27(7):824-832. doi: 10.1111/j.1468-2982.2007.01352.x
4. Glauser TA, Cnaan A, Shinnar S, et al. Ethosuximide, valproic acid, and lamotrigine in childhood absence epilepsy. N Engl J Med. 2010;362(9):790-799.
5. Grunze H, Vieta E, Goodwin GM, et al; WFSBP Task Force on Treatment Guidelines for Bipolar Disorders. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2010 on the treatment of acute bipolar depression. World J Biol Psychiatry. 2010;11(2):81-109. doi:10.3109/15622970903555881
6. Lamictal (lamotrigine) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; February 2023.
7. Lamictal ODT (lamotrigine) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; February 2023.
8. Lamictal XR (lamotrigine) [prescribing information]. Durham, NC: GlaxoSmithKline; January 2023.
9. May A, Leone M, Afra J, et al; EFNS Task Force. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias. Eur J Neurol. 2006;13(10):1066-1077. doi: 10.1111/j.1468-1331.2006.01566.x
10. Piña-Garza JE, Elterman RD, Ayala R, et al. Long-Term Tolerability and Efficacy of Lamotrigine inInfants 1 to 24 Months Old. J Child Neurol. 2008;23(8):853-861.
11. Piña-Garza JE, Levisohn P, Gucuyener K, et al. Adjunctive Lamotrigine for Partial Seizures inPatients Aged 1 to 24 Months. Neurology. 2008a;70(22, pt 2):2099-2108.
12. Schachter SC. Overview of the management of epilepsy in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed June 27, 2022.
13. Selle V, Schalkwijk S, Vázquez GH, Baldessarini RJ. Treatments for acute bipolar depression: meta-analyses of placebo-controlled, monotherapy trials of anticonvulsants, lithium andantipsychotics. Pharmacopsychiatry. 2014;47(2):43-52. doi:10.1055/s-0033-13632584
14. Taylor DM, Cornelius V, Smith L, Young AH. Comparative efficacy and acceptability of drug treatments for bipolar depression: a multiple-treatments meta-analysis. Acta Psychiatr Scand. 2014;130(6):452-469. doi:10.1111/acps.12343
15. Williams MH, Broadley SA. SUNCT and SUNA: clinical features and medical treatment. J Clin Neurosci. 2008;15(5):526-534. doi:10.1016/j.jocn.2006.09.006
16. Yatham LN, Kennedy SH, Parikh SV, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018;20(2):97-170. doi:10.1111/bdi.12609

Clinical Guideline Revision / History Information

Original Date: 11/05/2020

Reviewed/Revised: 10/14/2021, 12/01/2021, 9/15/2022, 9/21/2023